Hysterosalpingography
Conditions
Keywords
hysterosalpingography
Brief summary
This single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial evaluated the efficacy and safety of oral hyoscine butylbromide, topical lidocaine-prilocaine spray and placebo for reducing pain during hysterosalpingography in women with primary infertility. Pain was self-rated using an 11-point numerical rating scale at predefined procedural time points, including cervical instrumentation and uterine filling.
Detailed description
This was a single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial conducted at the Department of Obstetrics and Gynaecology, Al Gezeera Hospital, Giza, Egypt. Women aged 18-40 years with primary infertility scheduled for hysterosalpingography during the early proliferative phase of the menstrual cycle were randomly assigned in a 1:1:1 ratio to receive oral hyoscine butylbromide 20 mg with placebo cervical spray, topical lidocaine-prilocaine spray with placebo oral tablet, or double placebo. A double-dummy technique was used to preserve blinding across oral and topical routes of administration. Pain was assessed using a 0-10 numerical rating scale at predefined procedural time points. The primary outcome was pain during cervical instrumentation. Secondary outcomes included pain during uterine filling, pain after speculum insertion, pain 30 minutes after the procedure, patient satisfaction, rescue analgesia and adverse events.Before recruitment and randomisation of the first participant, the protocol was amended and approved by the Research Ethics Committee to specify the topical lidocaine-prilocaine spray formulation and the final outcome hierarchy described below. The registry record was subsequently updated during final study-data updating to reflect the approved amended protocol.
Interventions
DRUGOral Hyoscine butylbromide and Placebo Spray
Hyoscine butylbromide 20 mg oral tablet, single dose, administered 30 minutes before HSG, plus placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before HSG.
DRUGTopical lidocaine-prilocaine spray and placebo oral tablet
Topical lidocaine-prilocaine spray, Manovipercaine Plus, EVA Pharma, Egypt, containing lidocaine 15% and prilocaine 5%, applied as three sprays to the ectocervix and external cervical os 10 minutes before HSG, plus placebo oral tablet administered 30 minutes before HSG.
DRUGDouble Placebo
Placebo oral tablet administered 30 minutes before HSG plus placebo cervical spray applied 10 minutes before HSG, at the same time points as the active interventions.
Sponsors
Cairo University
Aljazeera Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18 to 40 years * Primary infertility * Scheduled to undergo hysterosalpingography as part of routine infertility evaluation * Regular menstrual cycles * Hysterosalpingography scheduled during the early proliferative phase of the menstrual cycle, days 6 to 12 * Negative urine pregnancy test on the day of the procedure * Able to understand and use the 0 to 10 Numerical Rating Scale for Pain assessment
Exclusion criteria
* Secondary infertility * Known hypersensitivity to hyoscine, lidocaine, or prilocaine * Use of systemic analgesics, sedatives, or antispasmodics within 24 hours before hysterosalpingography * Chronic pelvic pain or severe dysmenorrhoea requiring regular analgesia * Active pelvic infection * Known uterine anomaly * Cervical stenosis necessitating anaesthesia * History of contrast allergy * Inability to cooperate with numerical pain scoring * Current pregnancy * Severe systemic disease corresponding to American Society of Anesthesiologists physical status class III or higher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain during cervical instrumentation | Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection. | Pain intensity during cervical instrumentation, including tenaculum placement and cervical cannulation, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain after speculum insertion before cervical instrumentation | Intra-procedure, immediately after speculum insertion and before cervical instrumentation. | Pain intensity will be assessed immediately after speculum insertion and before tenaculum placement or cervical cannulation using the 11-point Numerical Rating Scale for Pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity. |
| Pain 30 minutes after HSG | 30 minutes post-procedure | Pain intensity will be assessed 30 minutes after completion of hysterosalpingography using the 11-point Numerical Rating Scale for Pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity. |
| Patient satisfaction 30 minutes after HSG | 30 minutes postprocedure | Patient satisfaction with the procedure, measured using a 0-10 satisfaction scale, where 0 indicates no satisfaction and 10 indicates maximum satisfaction. |
| Pain during uterine filling | During HSG, at the end of uterine filling / immediately after contrast injection. | Pain intensity during or immediately after contrast injection at the end of uterine filling, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Post-procedure rescue analgesia | After the 30-minute post-procedure pain assessment. | Number and percentage of participants requiring rescue analgesia after completion of the 30-minute post-procedure pain assessment. Rescue analgesia consisted of oral paracetamol 1,000 mg. |
| Adverse events related to study medications or hysterosalpingography | Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure. | Adverse events will be reported as the number and percentage of participants experiencing any adverse event potentially related to the study medications or the hysterosalpingography procedure. Events assessed will include dry mouth, nausea, dizziness, blurred vision, tachycardia, vasovagal reaction, allergic symptoms, local irritation or burning, and any other unexpected adverse event. |
| Serious adverse events related to study medications or hysterosalpingography | Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure. | Serious adverse events will be reported as the number and percentage of participants experiencing any serious adverse event during or after hysterosalpingography, including events requiring urgent medical intervention, hospital referral, or prolonged medical observation. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMahmoud Alalfy, MD
Algezeera Hospital
Outcome results
None listed